Natural Health Product (NHP) Compounding Policy

 

The Natural Health Products Directorate (NHPD) has changed its name to the Natural and Non-prescription Health Products Directorate (NNHPD) subsequent to its recently expanded mandate to include the oversight of non-prescription and disinfectant drugs in addition to natural health products (NHPs). Please note that we are currently modifying documents to reflect this change.

Thank you for your patience and understanding.

Natural Health Products Directorate,
Health Products and Food Branch, Health Canada

October 10, 2006

The summary of comments from the public consultation can be found in the Consultation Archives.

Table of Contents

  • Appendix I: Schedules 1 and 2 of the Natural Health Product Definition

I. Purpose

This policy outlines Health Canada's current approach with respect to compounding of NHPs.

The NHP Compounding Policy distinguishes between the manufacturing of natural health products, an activity regulated by the Natural Health Products Regulations (NHP Regulations), and the compounding of natural health products, an activity unregulated by NHP Regulations.

II. Background

The Natural Health Products Directorate (NHPD) recognizes the need to clearly define what is meant by compounding and to outline the implications and scope of this concept. The NHP Compounding Policy clarifies the distinction between the manufacturing and compounding of NHPs, including whether or not a site licence is required for a particular activity.

Recognizing the importance of stakeholder input in the development of the policy, the NHPD developed the Interim NHP Compounding Policy. NHPD consulted on this interim policy with Health Canada colleagues and health care practitioners, including pharmacists, Traditional Chinese Medicine practitioners, herbalists, naturopathic doctors, practitioners of Aboriginal medicine, homeopaths, etc.

Compounding is generally understood as a process whereby a health care practitioner mixes, or prepares health products (natural, medicinal, etc.) to an exact specification tailored to a patient's needs, and in a vehicle desired (cream, lotion, gel, drops, capsules, pellets, etc.). Compounding is generally used to:

  1. Provide products unavailable or not readily available in the specifications needed by a practitioner (e.g., strength) to address the specific health concerns, symptoms and needs of a particular patient, and/or to meet the specific requirements of a particular health care practice;
  2. Provide products free of preservatives, dyes and chemical allergens; and
  3. Prepare palatable flavoured dosage forms.

Compounding is an activity performed by a health care practitioner in the context of a practitioner-patient relationship. It is an activity that generally falls under provincial or territorial jurisdiction. A site licence is therefore not required to compound, and the compounded product does not require a product licence to be sold. Responsibility for the safety, efficacy and quality of the compounded product is assumed by the health care practitioner.

The practice of compounding is excluded from the scope of NHP Regulations through the manufacturer definition:

"Manufacturer" means a person who fabricates or processes a natural health product for the purpose of sale, but does not include a pharmacist or other health care practitioner who, at the request of a patient, compounds a natural health product for the purpose of sale to that patient.

It was never the intent of the NHP Regulations to regulate the practice of complementary and alternative or traditional medicine. The Regulatory Impact Analysis Statement (RIAS) published with the NHP Regulations in the Canada Gazette, Part II, contains a statement that clarifies this policy intent:

"Health care practitioners (for example, pharmacists, Traditional Chinese Medicine (TCM) practitioners, herbalists, naturopathic doctors, etc.) who compound products at the request of a patient are not included within the manufacturer definition. NHP Regulations are not aimed at regulating the practice of complementary and alternative health care practitioners or the practice of traditional Aboriginal medicine. The NHPD intends to adopt a guidance document regarding the distinction between manufacture and sale of NHPs and compounding and distribution of compounded products by complementary and alternative health care practitioners and Aboriginal healers."

NHPD will continue to work in partnership with practitioners to support Canadians in making safe and informed decisions about natural health products.

More information on the Natural Health Products Regulations can be found at:
Implementation of the Natural Health Products Regulations (NHP Regulations)

On January 1, 2004, the Natural Health Products Regulations came into force. The NHP Regulations contain requirements for the manufacture, packaging, labelling, storage, importation, distribution and sale of NHPs.

III. Scope

The NHP Compounding Policy will distinguish between the manufacturing of natural health products, an activity regulated by the Natural Health Products Regulations, and the compounding of natural health products.

IV. Definitions

Importer - means a person who imports a natural health product into Canada for the purpose of sale.

Manufacturer - means a person who fabricates or processes a natural health product for the purpose of sale, but does not include a pharmacist or other health care practitioner who, at the request of a patient, compounds a natural health product for the purpose of sale to that patient.

Natural health product - means a substance set out in Schedule 1 (see Appendix I) or a combination of substances in which all the medicinal ingredients are substances set out in Schedule 1, a homeopathic medicine or a traditional medicine, that is manufactured, sold or represented for use in

  1. the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
  2. restoring or correcting organic functions in humans; or
  3. modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.

However, a natural health product does not include a substance set out in Schedule 2 (see Appendix I), any combination of substances that includes a substance set out in Schedule 2 or a homeopathic medicine or a traditional medicine that is or includes a substance set out in Schedule 2.

For the purposes of these Regulations, a substance or combination of substances or a traditional medicine is not considered to be a natural health product if its sale, under the Food and Drug Regulations, is required to be pursuant to a prescription when it is sold other than in accordance with section C.01.043 of those Regulations.

Sell - includes offer for sale, expose for sale, have in possession for sale and distribute, whether or not the distribution is made for consideration (from the Food and Drugs Act).

V. Policy Statement

The table below includes various scenarios to distinguish between the manufacturing of NHPs and the compounding of NHPs. It also indicates when a site licence is required.

  • No site licence is required for the activity of compounding.
  • The product resulting from the practice of health care (in this case, compounding) does not require a product licence.
  • While some health care practitioners may not be regulated by the provinces or territories, they remain nonetheless responsible for the compounded product they provide to their patients.
  • There are certain activities which, because they are commercial in nature (for example, due to the volume of product made or the absence of a practitioner-patient relationship), do not fall within the scope of this policy. In such a case the Health Products and Food Branch Inspectorate could enforce the NHP Regulations with respect to this activity.
Scenario\Requirement for Site Licence
# Scenario\Requirement for Site Licence Site Licence Needed? Note
Yes No

Table 1 footnotes

Table 1 footnote 1

See the NHP Raw Material Policy for additional information pertaining to raw materials.

Return to table 1 footnote 1 referrer

Table 1 footnote 2

See the document entitled Manufacturing and Compounding Drug Products in Canada (June 15, 2000).

Return to table 1 footnote 2 referrer

1 Practitioner imports an NHP with NPN or DIN-HM or DIN into Canada and uses that NHP to compound product (DIN permitted on product to which the transitional provisions still apply). SL needed for importing only.
2 Practitioner uses an NHP with NPN or DIN-HM or DIN to compound product (DIN permitted on product to which the transitional provisions still apply).
3 Practitioner uses an NHP with neither an NPN nor DIN-HM nor a DIN to compound product.
4 Practitioner uses raw material to compound productTable 1 footnote 1.
5 Practitioner wildcrafts (i.e., herbs are harvested in the wild) or cultivates a herb for use in a compounded product.
6 Practitioner uses an NHP withdrawn from the market for safety reasons to compound product. Not applicable. Not permissible.
7 Practitioner uses any substance listed on Schedule 2 to the Natural Health Products Regulations to compound product. Not applicable. Not an NHP. This is compounding of a product that does not fit the NHP definitionTable 1 footnote 2.
8

Practitioner uses any substance that does not meet the NHP definition to compound product (e.g., prescription drugs (Schedule F ingredients), biologics, etc.).

Note that homeopathic medicines may contain Schedule F and Schedule D substances.

Not applicable. Not an NHP. This is compounding of a product that does not fit the NHP definition.
9 Practitioner compounds product for another practitioner to provide to his/her patients. This is compounding.
10 Practitioner provides a stock bottle (e.g., a tincture) to another practitioner to be used by that practitioner to compound product. This is compounding.
11 Practitioner uses a stock bottle (e.g., a tincture) provided by another practitioner to compound product. This is compounding.
12 Practitioner compounds product intended for distribution or sale outside the established practitioner-patient relationship. This is manufacturing.
13 Practitioner compounds a product in advance of a practitioner-patient relationship (i.e., bulk compounding) AND product is given to patient in the context of a practitioner-patient relationship.
14 Practitioner does the following (examples specific to homeopathic medicine):
  • Coats blank pellet with medicating potency
  • Adds water to medicated pellet
  • Crushes medicating pellet to make powder
  • Grafts
This is compounding.

Appendix I: Schedules 1 and 2 of the Natural Health Product Definition

Schedule 1 (Subsection 1(1))

Included Natural Health Product Substances
Item Substances
1. A plant or a plant material, an alga, a bacterium, a fungus or a non-human animal material
2. An extract or isolate of a substance described in item 1, the primary molecular structure of which is identical to that which it had prior to its extraction or isolation
3.

Any of the following vitamins:

  • biotin
  • folate
  • niacin
  • pantothenic acid
  • riboflavin
  • thiamine
  • vitamin A
  • vitamin B6
  • vitamin B12
  • vitamin C
  • vitamin D
  • vitamin E
  • vitamin K 1
  • vitamin K 2
4. An amino acid
5. An essential fatty acid
6. A synthetic duplicate of a substance described in any of items 2 to 5
7. A mineral
8. A probiotic

Schedule 2 (Subsection 1(1))

Excluded Natural Health Product Substances
Items Substances
1. A substance set out in Schedule C to the Act
2.

A substance set out in Schedule D to the Act, except for the following:

  1. a drug that is prepared from any of the following micro-organisms, namely, an alga, a bacterium or a fungus; and
  2. any substance set out on Schedule D when it is prepared in accordance with the practices of homeopathic pharmacy
3. A substance regulated under the Tobacco Act
4. A substance set out in any of Schedules I to V of the Controlled Drugs and Substances Act
5. A substance that is administered by puncturing the dermis
6. An antibiotic prepared from an alga, a bacterium or a fungus or a synthetic duplicate of that antibiotic
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